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Tislelizumab Combined With Chemotherapy as Neoadjuvant Therapy for Stage IIIA-IIIB (N2) Lung Squamous Cell Carcinoma (TACT)

Primary Purpose

Lung Squamous Cell Carcinoma, Neoadjuvant Therapy, Immunotherapy

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Squamous Cell Carcinoma focused on measuring Lung Squamous Cell Carcinoma, neoadjuvant therapy, immunotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The age is ≥18 years old and <75 years old.
  2. Eastern Cooperative Oncology Group (ECOG) physical status is 0 or 1.
  3. Untreated and histologically confirmed squamous cell lung carcinoma.
  4. Potentially operable stage IIIA-IIIB (N2) squamous cell lung carcinoma on enrollment (as defined by the American Joint Committee on Cancer 8th Edition).
  5. Sufficient pre-treatment tumor tissue samples/peripheral blood samples for biomarker analysis.
  6. Sufficient organ functions, including: Haematological status: absolute neutrophil count(ANC) ≥1.5×10^9 /L, platelet count(PLT) ≥100×10^9 /L, hemoglobin(HB) ≥90 g/L; Liver function: alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN); Kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN) or Creatinine clearance ≥45 ml/min (calculated according to Cockcroft-Gault equation)

Exclusion Criteria:

  1. Participants with known EGFR, ALK or ROS1 sensitive mutations.
  2. Participants with autoimmune diseases, tuberculosis, active hepatitis or HIV.
  3. Participants who are not expected to tolerate surgery, such as patients with cardiopulmonary insufficiency, etc.
  4. A history of other malignant tumors in the past 5 years, except for cured cervical carcinoma in situ, cured basal cell carcinoma of the skin and superficial bladder cancer [Ta, Tis & T1].
  5. Participants who have used PD-1/PD-L1 and other immunotherapy drugs before.
  6. Women of childbearing age as the exclusion criteria.

Sites / Locations

  • The First Affiliated Hospital, Zhejiang University School of medicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tislelizumab + Albumin Paclitaxel + Carboplatin

Arm Description

Tislelizumab 200mg d1, Albumin Paclitaxel 260mg/m2 d1, Carboplatin AUC5 d1, Q3W

Outcomes

Primary Outcome Measures

Major Pathological Response (MPR)
Major Pathological Response (MPR) is evaluated after resection by pathologists, which is defined as a metric of ≤10% residual tumor tissue after neoadjuvant therapy.
Incidence of Treatment-Emergent Adverse Events
Adverse events are evaluated by investigators according to CTCAE 5.0.

Secondary Outcome Measures

Rate of radical resection (R0)
The rate of radical resection (R0) is evaluated by the investigator, which is the number of participants who can undergo R0 resection after the evaluation criteria established by the MDT team divided by the total number of enrolled groups.
Overall Response Rate (ORR)
The overall response rate is evaluated by the investigator, which is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set (e.g. efficacy evaluable population)
Disease-free survival (DFS)
Disease-free survival (DFS) is evaluated by the investigator, which is the percentage of individuals in the treatment group who are likely to be free of the signs and symptoms of a disease after a specified duration of time.
Overall survival (OS)
Overall survival (OS) evaluated by the investigator, which is the percentage of people in a group who are alive after a length of time.

Full Information

First Posted
August 10, 2021
Last Updated
August 22, 2021
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05024266
Brief Title
Tislelizumab Combined With Chemotherapy as Neoadjuvant Therapy for Stage IIIA-IIIB (N2) Lung Squamous Cell Carcinoma
Acronym
TACT
Official Title
Tislelizumab Combined With Albumin Paclitaxel + Carboplatin as Neoadjuvant Therapy for Patients With Stage IIIA-IIIB (N2) Lung Squamous Cell Carcinoma: A Single-arm, Single-center, Exploratory Phase II Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Tislelizumab combined with chemotherapy has shown good efficacy and safety in clinical studies of lung adenocarcinoma (RATIONALE 304) and lung squamous cell carcinoma (RATIONALE 307), thus has been approved as the first-line therapy for advanced non-small cell lung cancer (NSCLC) in China. However, there is no data in the field of neoadjuvant therapy for NSCLC. This single-arm, single-center phase II clinical study is designed to evaluate the efficacy, safety and major pathological response (MPR) of Tislelizumab combined with chemotherapy as neoadjuvant therapy in patients with stage IIIA-IIIB (N2) lung squamous cell carcinoma. Biomarkers correlated with efficacy outcomes will also be explored.
Detailed Description
Tislelizumab combined with chemotherapy has shown good efficacy and safety in clinical studies of lung adenocarcinoma (RATIONALE 304) and lung squamous cell carcinoma (RATIONALE 307), thus has been approved as the first-line therapy for advanced non-small cell lung cancer (NSCLC) in China. However, there is no data in the field of neoadjuvant therapy for NSCLC. This single-arm, single-center phase II clinical study intends to enroll about 30 patients with potentially operable lung squamous cell carcinoma with clinical stages IIIA-IIIB (N2). Participants will intravenously receive tislelizumab (BeiGene, 200mg d1) + albumin paclitaxel 260mg/m2 d1 + carboplatin AUC 5 d1, Q3W, Imaging evaluation is performed after 2 cycles of medication, and the feasibility of surgery is discussed in multiple disciplines. If the evaluation is operable, the lesion will be surgically removed 22-40 days after the last treatment. If it is assessed to be reduced but still inoperable, the original plan will be continued for another cycle. Imaging examinations, tissue NGS (whole-exome sequencing), gene expression profiling (GEP), and PD-L1 expression will be performed at baseline, preoperative and postoperative respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Squamous Cell Carcinoma, Neoadjuvant Therapy, Immunotherapy
Keywords
Lung Squamous Cell Carcinoma, neoadjuvant therapy, immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tislelizumab + Albumin Paclitaxel + Carboplatin
Arm Type
Experimental
Arm Description
Tislelizumab 200mg d1, Albumin Paclitaxel 260mg/m2 d1, Carboplatin AUC5 d1, Q3W
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
Albumin Paclitaxel, Carboplatin
Intervention Description
Participants received 2 cycles Tislelizumab 200mg d1 + Albumin Paclitaxel 260mg/m2 d1 + Carboplatin AUC5 d1 every 3 weeks, and then were evaluated for surgery.
Primary Outcome Measure Information:
Title
Major Pathological Response (MPR)
Description
Major Pathological Response (MPR) is evaluated after resection by pathologists, which is defined as a metric of ≤10% residual tumor tissue after neoadjuvant therapy.
Time Frame
2-4 weeks after resection
Title
Incidence of Treatment-Emergent Adverse Events
Description
Adverse events are evaluated by investigators according to CTCAE 5.0.
Time Frame
Through the trial
Secondary Outcome Measure Information:
Title
Rate of radical resection (R0)
Description
The rate of radical resection (R0) is evaluated by the investigator, which is the number of participants who can undergo R0 resection after the evaluation criteria established by the MDT team divided by the total number of enrolled groups.
Time Frame
4 weeks after resection
Title
Overall Response Rate (ORR)
Description
The overall response rate is evaluated by the investigator, which is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set (e.g. efficacy evaluable population)
Time Frame
4 weeks after resection
Title
Disease-free survival (DFS)
Description
Disease-free survival (DFS) is evaluated by the investigator, which is the percentage of individuals in the treatment group who are likely to be free of the signs and symptoms of a disease after a specified duration of time.
Time Frame
1 year and 2 years after resection
Title
Overall survival (OS)
Description
Overall survival (OS) evaluated by the investigator, which is the percentage of people in a group who are alive after a length of time.
Time Frame
Through the trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The age is ≥18 years old and <75 years old. Eastern Cooperative Oncology Group (ECOG) physical status is 0 or 1. Untreated and histologically confirmed squamous cell lung carcinoma. Potentially operable stage IIIA-IIIB (N2) squamous cell lung carcinoma on enrollment (as defined by the American Joint Committee on Cancer 8th Edition). Sufficient pre-treatment tumor tissue samples/peripheral blood samples for biomarker analysis. Sufficient organ functions, including: Haematological status: absolute neutrophil count(ANC) ≥1.5×10^9 /L, platelet count(PLT) ≥100×10^9 /L, hemoglobin(HB) ≥90 g/L; Liver function: alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN); Kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN) or Creatinine clearance ≥45 ml/min (calculated according to Cockcroft-Gault equation) Exclusion Criteria: Participants with known EGFR, ALK or ROS1 sensitive mutations. Participants with autoimmune diseases, tuberculosis, active hepatitis or HIV. Participants who are not expected to tolerate surgery, such as patients with cardiopulmonary insufficiency, etc. A history of other malignant tumors in the past 5 years, except for cured cervical carcinoma in situ, cured basal cell carcinoma of the skin and superficial bladder cancer [Ta, Tis & T1]. Participants who have used PD-1/PD-L1 and other immunotherapy drugs before. Women of childbearing age as the exclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yujie Huang
Phone
0571-87236560
Email
zyct79@163.com
Facility Information:
Facility Name
The First Affiliated Hospital, Zhejiang University School of medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianzhen Shan
Phone
0571-87235409
Email
jianzhenshan@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tislelizumab Combined With Chemotherapy as Neoadjuvant Therapy for Stage IIIA-IIIB (N2) Lung Squamous Cell Carcinoma

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